Analytical Method Development and Validation
Our company excels in developing and validating analytical methods tailored to specific drug development phases, from early preclinical stages to commercial production. Our services include:
- Phase-Appropriate Method Development
- Chiral and Achiral Methodologies
- Impurity/Degradant Profiling
- Genotoxic Impurity and Trace Metal Analysis
- Analytical Method Validation
Quality Control for Manufacturing
We offer comprehensive QC solutions to ensure the quality and compliance of your pharmaceutical products throughout the manufacturing process. Our services include:
- Process Control Strategies
We implement robust process control strategies from Raw Material Sourcing (RSM) to Active Pharmaceutical Ingredient (API) to Drug Product (DP) manufacturing stages.
- Cleaning Method Validations
Our company conducts rigorous cleaning method validations and verifications to validate cleaning processes, ensuring equipment cleanliness and regulatory compliance.
Our expertise extends to formulation studies, including solubility, dissolution, disintegration, and permeability assessments. These studies are crucial for optimizing formulation parameters, evaluating drug delivery systems, and ensuring product efficacy.
Our company conducts thorough microbial limit testing, employing validated methods and adhering to pharmacopeial standards to ensure products meet microbial quality specifications.
- cGMP Batch Release Testing
Our company conducts cGMP batch release testing for API and drug products, including identity, potency, purity, and other relevant parameters, providing certification for market readiness.
- Forced Degradation Studies
Our company conducts forced degradation studies under accelerated conditions to assess product stability and degradation pathways.
Stability Services
Our ICH stability services encompass protocol development, rigorous testing under various storage conditions, and comprehensive stability study management. We help clients navigate stability requirements for IND/NDA/ANDA submissions, ensuring product efficacy and shelf-life determination.
*ICH: International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
